Avanir announced positive results from its Phase II trial evaluating the safety of AVP-923 in a 10-week study of 220 alzheimer’s patients. Treatment with AVP-923 resulted in a statistically significant reduction in agitation and caregiver burden.
Complete data will be presented at the American Neurological Association’s (ANA) 2014 Meeting , October 12-14. The company plans to request a meeting with the FDA and EMA for the purpose of discussing the advancement of AVP-923 into pivotal trials.
AVP-923 is a combination of the cough suppressant dextromethorphan hydrobromide and low-dose CYP2D6 inhibitor quinidine to increase its bioavailability. At high concentrations, dextromethorphan has activity against multiple neuro-receptors including NMDA, and sigma-1.
On Friday, NPS Pharmaceuticals received a positive 8-5 decision favor of the company’s experimental drug Natpara for the treatment of hypoparathyroidism, a condition in which a person fails to produce enough of the parathyroid hormone. This leads to low calcium levels, with symptoms such as muscle pain and tingling.
The FDA is expected to make an approval decision by October 24. Despite a nod from the expert panel, its split decision creates uncertainty over which direction the FDA will take, as it is not bound by the panel’s recommendation. NPS Pharmaceutical shares are down 14% today.
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